Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

University of Aarhus

ALK-Abelló A/S

Lundbeck Foundation

Information provided by:

Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT01085526

First received: March 10, 2010

Last updated: June 24, 2011

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 10, 2010

Last Updated Date

June 24, 2011

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

a significant decrease in basophil activity during and after treatment [ Time Frame: every 3 weeks for 3 months, then 3 monthly for 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

changes in basophil activity [ Time Frame: 3 weeks in 3 months, then 3 monthly for 3 years ] [ Designated as safety issue: No ]
changes in immunoglobulin concentrations [ Time Frame: every 3 months for 4 years ] [ Designated as safety issue: No ]
plasma cells [ Time Frame: 5 times in 3 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01085526 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

reduction in high affinity IgE receptor density on basophils and mast cells [ Time Frame: at inclusion and at the end of study ] [ Designated as safety issue: No ]
igE receptor density on basophils and mast cells from nasal mucosa
clinical outcome: reduction in the reaction to allergen challenge tests (skin and nose), significant better outcome in quality of life questionnaires and symptom/medication scores [ Time Frame: once yearly for 4 years ] [ Designated as safety issue: No ]
allergen challenging response
a significant increase in the number of plasma cells during up dosing [ Time Frame: 5 times during the first 3 months of the study ] [ Designated as safety issue: No ]
a significant shift in specific immunoglobulins from IgE at start to IgG1 and IgG4 after treatment. allergen epitope specific IgE and IgG4 [ Time Frame: every 3 months for 4 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

IgE receptor [ Time Frame: at inclusion and at the end of study ] [ Designated as safety issue: No ]
igE receptor density on basophils and mast cells from nasal mucosa
clinical outcome [ Time Frame: once yearly for 4 years ] [ Designated as safety issue: No ]
allergen challgenging response

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis

Official Title ^ICMJE

Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Patients With Allergic Rhinitis Due to Grass Pollen Allergy - a Prospective Randomized Controlled Study

Brief Summary

The trial is randomized prospective study to examine the effects of subcutaneous immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to treatment or control group. The effect measures are changes in the basophil activity and biology as well as changes in plasma cells during and after treatment. Clinical outcome is assessed by QoL questionnaires and clinical testing.

Hypotheses:

changes in plasma cells correlate to changes in immunoglobulins and effector cell responses
the reduction of inflammation due to SCIT has influence on the effector cell responses
changes in paraclinical measurements can be related to clinical findings

Detailed Description

The investigators are recruiting 30 participants, which are randomized to receive SCIT (24) or no treatment (6) The following will be measured

the development of immunoglobulin response
plasma cells under updosing phase
changes in basophil activity under updosing and maintenance treatment
subtyping of allergic sensitization
clinical outcome and quality of life
changes in mast cells in the nasal mucosa
changes in the cell biology of the basophils

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Allergic Rhinoconjunctivitis

Intervention ^ICMJE

Biological: Alutard phleum pratense subcutaneous immunotherapy
standard regimen of SCIT
Other Names:
- alutard phleum pratense
- subcutaneous immunotherapy
Biological: no treatment
no treatment

Study Arm (s)

Active Comparator: alutard phl prat. treatment group: plasma cells
18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured

Intervention: Biological: Alutard phleum pratense subcutaneous immunotherapy
No Intervention: control
control group: basophil activity, basophil biology, plasma cells

Intervention: Biological: no treatment
Active Comparator: alutard phl.prat., treatment2, basophil biology
basophil activity, basophil biology measured

Intervention: Biological: Alutard phleum pratense subcutaneous immunotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2014

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

rhinoconjunctivitis due to grass pollen allergy
positive skin prick test and nasal allergen challenge test to grass pollen extract

Exclusion Criteria:

severe comorbidity, severe asthma, pregnancy

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01085526

Other Study ID Numbers ^ICMJE

BasoScit

Has Data Monitoring Committee

Yes

Responsible Party

Prof. Dr, med Ronald Dahl, Department of Respiratory Medicine, Århus University Hospital, Århus, Denmark, Århus University Hospital

Study Sponsor ^ICMJE

Aarhus University Hospital

Collaborators ^ICMJE

University of Aarhus
ALK-Abelló A/S
Lundbeck Foundation

Investigators ^ICMJE

Study Chair:	Ronald Dahl, Prof, dr.med	Dept. of Respiratory Medicine, Århus University Hospital
Principal Investigator:	Hans Juergen Hoffmann, assoc prof	Dept of Respiratory Medicine, Århus University Hospital
Principal Investigator:	Johannes M Schmid, MD	Dept. of Respiratory Medicine, Aarhus University Hospital

Information Provided By

Aarhus University Hospital

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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